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Denominator effects on traumatic occupational fatality incidence rates.

Each year over 6,000 workers are killed while earning a living in the United States. From these deaths, how can researchers determine if employees in the manufacturing industry are at greater risk of a traumatic occupational fatality than those employed in agriculture or any other industry? Similarly, does the risk of traumatic occupational fatality differ among states? To answer such questions, two measurements are normally used: frequency of occurrence and incidence rate. These measures are used to identify worker groups at greatest risk of fatal injury, target research and prevention activities, and evaluate the impact of these activities. Developing the best methods to accurately identify worker groups at greatest risk of losing their life while at work is always important, but even more so in times of limited government resources. The accuracy of a traumatic occupational fatality incidence rate depends on how closely the denominator and numerator represent the same population. Selecting data from different employment programs for the denominator when calculating incidence rates using the National Traumatic Occupational Fatalities surveillance system for the numerator has shown dramatically different results. This analysis points out that researchers must carefully: choose the data they employ; evaluate the meaning of calculated incidence rates; and document the data sources to ensure proper interpretation by others. Additional research and evaluation are necessary to improve data sources, analytical methods and tools to ensure effective resource allocations for the occupational safety and health field.

Accidents, Occupational↗

Acute urinary retention: risks and management.

Acute urinary retention (AUR) secondary to benign prostatic hyperplasia has in the past represented an immediate indication for surgery, and today most patients failing to void after an attempt at catheter removal still undergo surgery. The concept that this disease is in fact progressive in nature is slowly being accepted. Descriptive and analytical epidemiological data have shown that the incidence rate per 1000 person-years is less variable in the community than previously assumed; however, the risk is cumulative and increases with advancing age. The risk for patients diagnosed with benign prostatic hyperplasia is naturally higher, and analytical epidemiology has identified several strong risk factors, the most important one being serum prostate-specific antigen (PSA). In addition, prostate volume, maximum flow rate, and symptom severity should be considered when counseling patients presenting with lower urinary tract symptoms and clinical benign prostatic hyperplasia who are considering a course of watchful waiting. Efforts toward primary prevention of AUR should be directed to patients at increased risk, ie, those who are older and have more severe symptoms, larger glands, and higher PSA values. Risk reduction with finasteride has been demonstrated, and alpha-blockers have been shown to aid patients in achieving spontaneous voiding after an episode of AUR.

Journal Article↗

Interpretation of high-throughput liquid chromatography mass spectrometry data for quality control analysis and analytical method development.

An approach to rapidly process and interpret high-throughput liquid chromatography mass spectrometry data is presented. This approach applies an in-house developed computer application to process LC-MS report files containing spectral and chromatographic data from four different detectors (i.e. electrospray positive ionization, electrospray negative ionization mass spectrometry, UV absorption, and evaporative light scattering detection). Properties characteristic of detection and chromatographic retention are extracted and populated into a database. Approaches to applying this analytical information database for quality control analysis of ca. 400,000 samples are presented. Compound quality assessment methods employing average purity and detection data fields are compared to methods employing multiple quality control criteria (e.g. detection, purity, retention, and signal to noise). Structural similarity searches were applied with the analytical information database to identify compounds that may be undetectable by electrospray mass spectrometry. In addition, an approach to applying the database to aid in the selection of analytical detection and chromatography conditions for rapid analytical method development is also discussed.

Chromatography, Liquid↗

Security and confidentiality of health information systems: implications for physicians.

Adopting and developing the new generation of information systems will be essential to remain competitive in a quality conscious health care environment. These systems enable physicians to document patient encounters and aggregate the information from the population they treat, while capturing detailed data on chronic medical conditions, medications, treatment plans, risk factors, severity of conditions, and health care resource utilization and management. Today, the knowledge-based information systems should offer instant, around-the-clock access for the provider, support simple order entry, facilitate data capture and retrieval, and provide eligibility verification, electronic authentication, prescription writing, security, and reporting that benchmarks outcomes management based upon clinical/financial decisions and treatment plans. It is an integral part of any information system to incorporate and integrate transactional (financial/administrative) information, as well as analytical (clinical/medical) data in a user-friendly, readily accessible, and secure form. This article explores the technical, financial, logistical, and behavioral obstacles on the way to the Promised Land.

Computer Security↗

The UMD-p53 database: new mutations and analysis tools.

The tumor suppressor gene TP53 (p53) is the most extensively studied gene involved in human cancers. More than 1,400 publications have reported mutations of this gene in 150 cancer types for a total of 14,971 mutations. To exploit this huge bulk of data, specific analytic tools were highly warranted. We therefore developed a locus-specific database software called UMD-p53. This database compiles all somatic and germline mutations as well as polymorphisms of the TP53 gene which have been reported in the published literature since 1989, or unpublished data submitted to the database curators. The database is available at www.umd.necker.fr or at http://p53.curie.fr/. In this paper, we describe recent developments of the UMD-p53 database. These developments include new fields and routines. For example, the analysis of putative acceptor or donor splice sites is now automated and gives new insight for the causal role of "silent mutations." Other routines have also been created such as the prescreening module, the UV module, and the cancer distribution module. These new improvements will help users not only for molecular epidemiology and pharmacogenetic studies but also for patient-based studies. To achieve theses purposes we have designed a procedure to check and validate data in order to reach the highest quality data.

Databases, Genetic↗

Options for handling missing data in the Health Utilities Index Mark 3.

BACKGROUND: The Health Utilities Index Mark 3 (HUI3) is a tool composed of 41 questions, covering 8 attributes: vision, hearing, speech, ambulation, dexterity, emotion, cognition, and pain. Responses to these questions can define more than 972,000 health situations. This tool allows respondents to answer "Don't Know," for which there is no scoring instruction, to any given question. This situation creates a break in the scoring algorithm and leads to considerable amounts of missing data. The goal of this study is to develop strategies to deal with HUI3 scores for participants who have missing data. METHODS: The authors used data from 248 individuals enrolled in the Cataract Management Trial, focusing on the HUI3 vision and ambulation attributes, which had 19% and 10% of attribute levels missing, respectively. Inspection and deduction were used to fill in values independent of the value of the missing data, then alternative analytic techniques were compared, including mean substitution, model scoring, hot deck, multiple imputation, and regression imputation. RESULTS: Inspection and logical deduction reduced the percentage of missing information in the HUI3 by 49% to 87%. A comparison of analytic techniques used for the remaining HUI3 vision data missing demonstrated the value of building models based on internal response patterns and that simple analytic techniques fare as well as more complicated ones when the number of missing cases is small. CONCLUSION: Analyzing the pattern of responses in cases where the attribute level score is missing reduces the amount of missing data and can simplify the analytic process for the remaining missing data.

Activities of Daily Living↗

The mechanism of ethylene glycol ether reproductive and developmental toxicity and evidence for adverse effects in humans.

Numerous experimental studies have established that only a few among the large family of ethylene glycol ethers (EGEs) elicit toxicity on reproduction in either gender. Notable are the monomethyl (EGME) and monoethyl (EGEE) ethers and their respective acetate esters whose production volumes have dramatically declined. Oxidation to the respective monoalkoxy acids is a prerequisite for toxicity. The most potent EGE reproductive toxicant is EGME (via 2-methoxyacetic acid; MAA), which elicits developmental phase-specific insults on either conceptus or on testes. Toxicity at either target site is markedly attenuated by simple physiological compounds such as acetate, formate, glycine, D-glucose and serine. Lack of solid EGME occupational exposure data and the need to improve the scientific foundations for animal data extrapolations, prompted the development of physiologically based pharmacokinetic (PBPK) models for pregnancy application. Interspecies (mouse-rat) and different exposure routes (including inhalation) were experimentally validated. Such PBPK models were then extrapolated to potential occupational exposures, using rather limited human MAA pharmacokinetic data. PBPK model predictions of human blood levels upon simulated inhalation exposure to the 5 ppm threshold limit value (TLV) for 8 h were approximately 60 microM were well below those causing adverse effects in pregnant mice or rats. This conclusion concurs with the lack of objective analytical chemistry data for EGME/MAA in occupational settings, regardless of the potential route of exposure. There are no exposure data that can be linked in a cause-and-effect association to adverse human reproductive outcomes.

Abnormalities, Drug-Induced↗

Monochlorobenzene marine risk assessment with special reference to the OSPARCOM region: North Sea.

This risk assessment on monochlorobenzene was carried out for the marine environment, following methodology given in the EU risk assessment Regulation (1488/94) and Guidance Document of the EU New and Existing Substances Regulation (TGD, 1996). Data from analytical monitoring programmes in large rivers and estuaries in the North Sea area were collected and evaluated for effects and environmental concentrations. Risk is indicated by the ratio of predicted environmental concentration (PEC) to predicted no-effect concentration (PNEC) for the marine aquatic environment. In total, 27 data for fish, 24 data for invertebrates and 13 data for algae were evaluated. Acute and chronic toxicity studies were taken into account and appropriate assessment factors used to define a final PNEC value of 32 micro/l. Recent monitoring data indicate that monochlorobenzene levels in surface waters are below determination limits of 0.1, 0.2, 0.5 microg/l used in monitoring programs. Assuming that half of the lowest determination (0.1 microg/l) is typical, a PEC of 0.05 microg/l was derived. A worst case of 0.5 microg/l is assumed. PEC/PNEC ratios give safety factors of 60 to over 500, taking no account of dilution in the sea. Monochlorobenzene is not a 'toxic, persistent and liable to bioaccumulate' substance sensu the Oslo and Paris Conventions for the Prevention of Marine Pollution (OSPAR-DYNAMEC) criteria. Environmental fate and effects data indicate that current use of monochlorobenzene poses no unacceptable risk to the aquatic environment.

Animals↗

1,2-dichlorobenzene marine risk assessment with special reference to the OSPARCOM region: North Sea.

This risk assessment on 1,2-dichlorobenzene was carried out for the marine environment, following methodology given in the EU risk assessment Regulation (1488/94) and Guidance Document of the EU New and Existing Substances Regulation (TGD, 1996). Data from analytical monitoring programmes in large rivers and estuaries in the North Sea area were collected and evaluated on effects and environmental concentrations. Risk is indicated by the ratio of predicted environmental concentration (PEC) to predicted no-effect concentration (PNEC) for the marine aquatic environment. In total, 26 data for fish, 24 data for invertebrates and 17 data for algae were evaluated. Acute and chronic toxicity studies were taken into account and appropriate assessment factors used to define a final PNEC value of 37 microg/l. All available monitoring data indicate that 1,2-dichlorobenzene levels in estuaries are below 0.1 microg/l. Worst case concentrations in rivers are below 0.45 microg/l. With this value, calculated PEC/PNEC ratios give safety margins of 100 to 300, taking no account of dilution in the sea. 1,2-dichlorobenzene is not a 'toxic, persistent and liable to bioaccumulate' substance sensu the Oslo and Paris Convention for the Prevention of Marine Pollution (OSPAR-DYNAMEC) criteria. Environmental fate and effects data indicate that current use of 1,2-dichlorobenzene poses no risk to the aquatic environment.

Animals↗

1,4-dichlorobenzene marine risk assessment with special reference to the OSPARCOM region: North Sea.

This risk assessment on 1,4-dichlorobenzene was carried out for the marine environment, following methodology given in the EU risk assessment Regulation (1488/94) and Guidance Document of the EU New and Existing Substances Regulation (TGD, 1996). Data from analytical monitoring programs in large rivers and estuaries in the North Sea area were collected and evaluated on effects and environmental concentrations. Risk is indicated by the ratio of predicted environmental concentration (PEC) to predicted no-effect concentration (PNEC) for the marine aquatic environment. In total, 17 data for fish, 9 data for invertebrates and 7 data for algae were evaluated. Acute and chronic toxicity studies were taken into account and appropriate assessment factors used to define a final PNEC value of 20 microg/l. Recent monitoring data indicate that 1,4-dichlorobenzene levels in coastal waters and estuaries are below the determination limit of 0.1 microg/l used in monitoring programs. The worst case value recorded in river water is below 0.45 microg/l. Using these values, calculated PEC/PNEC ratios give safety margins of about 40-200, taking no account of dilution in the sea. Environmental fate and bioaccumulation data indicate that current use of 1,4-dichlorobenzene poses no risk to the aquatic environment.

Animals↗

High-performance liquid chromatography-time-of-flight mass spectrometry and its application to peptide analyses.

High-performance liquid chromatography (HPLC) has been successfully interfaced on-line with liquid secondary-ion time-of-flight mass spectrometry, utilizing a continuous-flow interface. Time-of-flight mass spectrometry (TOF-MS) is a low-resolution, high-mass-range technique, compatible with extremely rapid data acquisition rates. Thus a TOF-MS system is extremely well suited for coupling with HPLC. This paper describes the interface used to couple the HPLC and TOF-MS as well as the basic operating principles of such a system. Using both standard and packed-capillary reversed-phase HPLC columns, the HPLC-TOF-MS system has been successfully used to separate and detect peptides, providing molecular weight information for the peptide analytes. Experimental data, including chromatograms (UV, reconstructed ion and selected ion) and mass spectra, are presented to demonstrate the ability of the HPLC-liquid secondary-ion TOF-MS system to resolve chromatographically analytes as well as to resolve mass spectrometrically analytes which are unresolved on the chromatographic column.

Chromatography, High Pressure Liquid↗

Handling of dioxin measurement data in the presence of non-detectable values: overview of available methods and their application in the Seveso chloracne study.

Exposure measurements of concentrations that are non-detectable or near the detection limit (DL) are common in environmental research. Proper statistical treatment of non-detects is critical to avoid bias and unnecessary loss of information. In the present work, we present an overview of possible statistical strategies for handling non-detectable values, including deletion, simple substitution, distributional methods, and distribution-based imputation. Simple substitution methods (e.g., substituting 0, DL/2, DL/ radical2, or DL for the non-detects) are the most commonly applied, even though the EPA Guidance for Data Quality Assessment discouraged their use when the percentage of non-detects is >15%. Distribution-based multiple imputation methods, also known as robust or "fill-in" procedures, may produce dependable results even when 50-70% of the observations are non-detects and can be performed using commonly available statistical software. Any statistical analysis can be conducted on the imputed datasets. Results properly reflect the presence of non-detectable values and produce valid statistical inference. We describe the use of distribution-based multiple imputation in a recent investigation conducted on subjects from the Seveso population exposed to 2,3,7,8-tetrachlorodibenzo-p-dioxin (TCDD), in which 55.6% of plasma TCDD measurements were non-detects. We suggest that distribution-based multiple imputation be the preferred method to analyze environmental data when substantial proportions of observations are non-detects.

Acne Vulgaris↗

NTP Toxicology and Carcinogenesis Studies of Trichloroethylene (CAS No. 79-01-6) in Four Strains of Rats (ACI, August, Marshall, Osborne-Mendel) (Gavage Studies).

Trichloroethylene is an industrial solvent used primarily for vapor degreasing and cold cleaning. It was selected for study because of its industrial use and for potential for human exposure. (An estimated 3.5 million workers are exposed to trichloroethylene.) In an earlier study trichloroethylene (stabilized with epichlorohydrin and 1,2-epoxybutane) administered by gavage caused hepatocellular carcinomas in male and female B6C3F1 mice. Trichloroethylene administration did not increase the incidence of tumors in male or female Osborne-Mendel rats. However, the survival of dosed rats was reduced, thereby compromising the sensitivity of the study to detect a carcinogenic effect. The studies described in this report were conducted to compare the sensitivities of four strains of rats (ACI, August, Marshall, and Osborne-Mendel) to diisopropylamine-stabilized trichloroethylene. The results of the present studies demonstrate that long-term administration of trichloroethylene produces nephrotoxicity in four strains of rats and that the susceptibilities of these strains to the nephrotoxic effects of the chemical are similar. Because of chemically induced toxicity, reduced survival, and incomplete documentation of the experimental data, the studies are considered inadequate for either comparing or assessing trichloroethylene-induced carcinogenesis in these strains of rats. Toxicology and carcinogenesis studies of trichloroethylene (more than 99% pure, stabilized with 8 ppm diisopropylamine) were conducted by administering the chemical in corn oil gavage at doses of 0, 500, or 1,000 mg/kg per day, 5 day per week, for 103 weeks to groups of 50 male and 50 female ACI, August, Marshall, and Osborne-Mendel rats. The doses were selected on the basis of results from 13-week gavage studies in which groups of 10 male and 10 female ACI, August, and Marshall rats received daily doses or trichloroethylene (male: 125-2,000 mg/kg; female: 63-1,000 mg/kg). Doses for Osborne-Mendel rats were selected to conform with doses used in an earlier carcinogenicity study in that strain (TR-2). In the 13-week studies, male ACI and August rats receiving 2,000 mg/kg trichloroethylene and male and female Marshall rats receiving 1,835 mg/kg had final mean body weights 12%-17% lower than those of the vehicle controls. All other dose groups had body weights comparable to those of the vehicle controls. Three male August rats dosed with 2,000 mg/kg died. Histopathologic evaluation of tissues revealed no lesions attributable to trichloroethylene administration in the 13-week studies. This absence of histopathologic findings did not accurately predict the nephrotoxic effects of long-term administration of trichloroethylene to rats. Body Weight and Survival in the Two-Year Studies: In the 2-year studies, all dosed groups exhibited some reduction in mean body weights relative to the vehicle controls. Survival relative to vehicle controls was significantly reduced in 7/16 dosed groups (see page 6 of the Technical Report). Also, the survival of high dose male Marshall rats was reduced by a large number of accidental deaths. Nephrotoxicity, reduced survival, and central nervous system toxicity (characterized by sedation, loss of consciousness, tremors, and convulsions) showed that the doses of trichloroethylene selected for the 2-year studies were too high. Renal Effects in the Two-Year Studies: Trichloroethylene caused tubular cell cytomegaly in 82%-100% of all dosed animals. In addition, trichloroethylene produced toxic nephropathy (which was distinguishable from age-related nephropathy) in 17%-80% of the dosed animals. Cytomegaly, karyomegaly, or toxic nephropathy was not found in untreated or vehicle control animals. Trichloroethylene administration was also associated with increased incidences of renal tubular cell adenomas and adenocarcinomas. The incidences of renal lesions are shown in the following table (see page 7 of Technical Report). Other Pathologic Effects in the Two-Year Studies: An increased incidence of interstitial cell tumors of the testis was observinterstitial cell tumors of the testis was observed in high dose male Marshall rats (untreated control, 16/46; vehicle control, 17/46; low dose, 21/48; high dose, 32/48; P=0.002). The incidences of pheochromocytomas of the adrenal gland were significantly reduced in male ACI, female August, female Marshall, and male and female Osborne-Mendel rats. Genetic Toxicology: Trichloroethylene did not cause mutations in Salmonella typhimurium strains TA98, TA100, TA1535, or TA1537 with or without metabolic activation. In Chinese hamster ovary cells, trichloroethylene did not induce chromosomal aberrations; the results for sister chromatid exchanges were considered positive. Trichloroethylene was mutagenic to mouse L5178Y lymphoma cells in the presence of rat liver S9. Data Audit: Audits of the experimental data for these 2-year studies of trichloroethylene were conducted by the National Toxicology Program (see Appendix Q of the Technical Report). The results of the audits revealed evidence that the doses of trichloroethylene were too high. In addition, there was insufficient documentation of animal breeding, clinical observations, environmental conditions, and analytical chemistry data. Also, individual animal identification was not always verifiable. Conclusions: Under the conditions of these 2-year gavage studies of trichloroethylene in male and female ACI, August, Marshall, and Osborne-Mendel rats, trichloroethylene administration caused renal tubular cell cytomegaly and toxic nephropathy in both sexes of the four strains. However, these are considered to be inadequate studies of carcinogenic activity because of chemically induced toxicity, reduced survival, and deficiencies in the conduct of the studies. Despite these limitations, tubular cell neoplasms of the kidney were observed in rats exposed to trichloroethylene and interstitial cell neoplasms of the testis were observed in Marshall rats exposed to trichloroethylene. Synonyms: acetylene trichloride; 1-chloro-2,2-dichloroethylene; 1,1-dichloro-2-chloroethylene; ethinyl trichloride; ethylene trichloride; 1,1,2-trichloroethylene; trichloroethene Trade names of formulations: Algylen; Anamenth; Benzinol; Blacosolv; Blancosolv; Cecolene; Chlorilen; Chlorylea; Chorylen; Circosolv; Crawhaspol; Densinfluat; Dow-Tri; Dukeron; Fleck-Flip; Flock Flip; Fluate; Gemalgene; Germalgene; Lanadin; Lethurin; Narcogen; Narkogen; Narkosoid; Nialk; Perma-A-Chlor; Perm-A-Clor; Petzinol; Philex; Threthylen; Threthylene; Trethylene; Tri; Triad; Trial; Triasol; Trichloran; Trichloren; Triclene; Tri-Clene; Trielene; Trielin; Triklone; Trilen; Trilene; Triline; Trimar; Triol; TRI-plus; TRI-plus M; Vestrol; Vitran; Westrosol Target Organs & Incidences from 2-year Studies

Journal Article↗

Toward real-time quantification of driving risks: a systematic review and research agenda of risk field theory.

In complex traffic systems, driving risk often evolves in a continuous and progressive manner prior to crash occurrence. How to effectively represent and analyze such latent risk states remains a central challenge in traffic safety research. In recent years, risk field-based approaches have introduced spatial and spatiotemporal continuous modeling paradigms, providing new perspectives for characterizing the distribution of traffic risk and its dynamic evolution. Motivated by the rapid growth of this research area and the lack of a systematic synthesis, this paper presents a comprehensive review of studies applying risk field theory to driving safety and traffic risk analysis. Following the PRISMA guidelines, relevant literature was collected through multi-database searches and analyzed using a combination of bibliometric analysis and qualitative review. The review systematically summarizes the theoretical foundations, modeling elements, data sources, analytical methods, and application domains of risk field-related research. Particular attention is given to studies that conceptualize traffic risk as a continuous field, complemented by a broader review of traffic risk factor literature to identify key elements and analytical dimensions involved in risk field modeling. On this basis, the paper synthesizes research progress in major application areas, including traffic safety state representation, driving behavior analysis, traffic conflict assessment, and autonomous driving and human-machine cooperative systems. Differences and commonalities among existing studies are compared in terms of modeling strategies, data support, and application scenarios. Through this systematic review, the paper clarifies the main research themes and methodological trends of risk field-based studies, providing a structured framework for understanding the evolution and application of this approach and offering methodological insights for risk perception modeling and safety-oriented decision support in intelligent transportation systems (ITS).

Humans↗

Second-order advantage achieved with four-way fluorescence excitation-emission-kinetic data processed by parallel factor analysis and trilinear least-squares. Determination of methotrexate and leucovorin in human urine.

Four-way fluorescence data recorded by following the kinetic evolution of excitation-emission fluorescence matrices (EEMs) have been analyzed by parallel factor analysis and trilinear least-squares algorithms. These methodologies exploit the second-order advantage of the studied data, allowing analyte concentrations to be estimated even in the presence of an uncalibrated fluorescent background. They were applied to the simultaneous determination of the components of the anticancer combination of methotrexate and leucovorin in human urine samples. Both analytes were converted into highly fluorescent compounds by oxidation with potassium permanganate, and the kinetics of the reaction was continuously monitored by recording full EEM of the samples at different reaction times. A commercial fast scanning spectrofluorometer has been used for the first time to measure the four-way EEM kinetic data. The rapid scanning instrument allows the acquisition of a complete EEM in 12 s at a wavelength scanning speed of 24 000 nm/min. The emission spectra were recorded from 335 to 490 nm at 5-nm intervals, exciting from 255 to 315 nm at 6-nm intervals. Ten successive EEMs were measured at 72-s intervals, to follow the fluorescence kinetic evolution of the mixture components. Good recoveries were obtained in synthetic binary samples and also in spiked urine samples. The excitation, emission, and kinetic time profiles recovered by both chemometric techniques are in good agreement with experimental observations.

Humans↗

A charcoal sampling method and a colorimetric analytical procedure for carbon disulfide. Measurement data from a viscose rayon manufacturing plant.

A charcoal sampling method and a colorimetric analytical method for carbon disulfide were developed. The methods were validated at relevant concentration of CS2. Precision and accuracy were acceptable (23%-6% and 36%-1%) at 25-400 micrograms CS2 deposited on the solid sorbent. The methods were calibrated with charcoal tube sampling and GC-FPD analysis. Regression analysis was performed on duplicate samples and a correlation coefficient of 0.96 and a regression coefficient of 0.8 were obtained. Occupational hygiene measurements were performed in a rayon manufacturing plant. A great proportion of TWA concentrations exceeded the swedish TLV (16 mg/m3) at all sample sites.

Air Pollutants, Occupational↗

Comparison and meta-analysis of randomized trials of endarterectomy for symptomatic carotid artery stenosis.

OBJECTIVE: Comparison and meta-analysis of randomized trials of carotid endarterectomy for symptomatic stenosis of the extracranial carotid artery. BACKGROUND: Randomized trials (North American Symptomatic Carotid Endarterectomy Trial [NASCET], the European Carotid Surgery Trial [ECST], and the VA Cooperative Study [VACS]) each show that carotid endarterectomy improves outcomes in selected symptomatic patients with high-grade extracranial carotid artery stenosis. Direct comparisons among the studies have not been possible because of differing methodologies, endpoints, and formats of data reporting. DESIGN/METHODS: Data for specified endpoints and corresponding person-years at risk were obtained for each trial. The rates of nonfatal stroke, nonfatal myocardial infarction, or death for surgically or medically treated patients in the perioperative period (30 days) and thereafter were compared (both including and excluding perioperative events) and then combined using meta-analytic techniques. Data from NASCET and ECST were also analyzed for differences in outcomes by sex. RESULTS: Event rate estimates (with 95% confidence intervals [95% CI]) for the first 30 days (events per person-year, primarily nonfatal stroke) for medically treated patients were 0.44 (0.22 to 0.76) for NASCET, 0.15 (0.04 to 0.38) for ECST, and 0.27 (0.03 to 0.96) for VACS. For surgically treated patients, the corresponding rates (per person-year) were 0.78 (0.49 to 1.19), 0.63 (0.41 to 0.94), and 1.27 (0.58 to 2.43). Event rates per year after 30 days were higher for medically treated patients (0.20 [0.16 to 0.25] versus 0.08 [0.05 to 0.11] for NASCET; 0.12 [0.10 to 0.15] versus 0.07 [0.06 to 0.09] for ECST; and 0.15 [0.07 to 0.25] versus 0.07 [0.03 to 0.16] for VACS). There were no significant differences among the trials, with an overall benefit for surgical therapy (risk ratio estimate, RR = 0.67, 95% CI = 0.54 to 0.83). There were no significant sex-based differences between NASCET and ECST and the overall benefit was not significantly different for men and women (RR = 0.58, 95% CI = 0.45 to 0.74 for men; RR = 0.84, 95% CI = 0.57 to 1.25 for women). CONCLUSIONS: Adjusting for primary endpoints and duration of follow-up, carotid endarterectomy has a similar benefit for symptomatic patients across trials and a similar benefit for men and women.

Aged↗

Integration of text, image, and graphic data from different sources in laboratory reports: example of kidney stone reporting system.

Laboratory analyses may generate multiple data types that may reside in disparate systems, and combining data into a report often requires laborious, error-prone methods. Kidney stone analysis, which includes biochemical composition analysis and gross feature documentation, is an example of such a situation. We developed the kidney stone reporting system (KISS) that integrates patient and specimen information from the laboratory information system, digital images of stones, and analytic instrument data into a concise report for the ordering clinicians. The database management environment facilitates archival and retrieval capabilities. Implementation of the system has reduced the number of manual steps necessary to produce a report and has saved approximately 30 technologist hours per week. Transcription errors have been virtually eliminated. The KISS represents an innovative use of standard tools to integrate text, image, and graphic data from disparate systems into an integrated laboratory report, without the need for expensive interfaces.

Clinical Laboratory Information Systems↗